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Last Updated: March 26, 2026

Details for Patent: 7,959,946


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Summary for Patent: 7,959,946
Title:Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Abstract:A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.
Inventor(s):Unchalee Kositprapa, Robert I. Goldfarb, John R. Cardinal, Avinash Nangia
Assignee:Actavis Holdco US Inc
Application Number:US10/777,542
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,959,946
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Formulation; Device;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis for U.S. Patent 7,959,946


Overview and Patent Summary

U.S. Patent 7,959,946 (issued June 14, 2011) covers a pharmaceutical invention related to novel compounds, formulations, or methods intended for specific therapeutic applications. Its focus appears to be on a class of chemical compounds with potential pharmaceutical utility, likely in the treatment of conditions such as cancer, autoimmune disorders, or infections. Exact claims delineate the scope of the patent and determine its enforceability and potential for licensing or litigation.


Claims Analysis

The patent contains multiple claims, primarily categorized into independent and dependent claims. They typically specify the chemical structure, method of use, or formulation.

Key points of the claims:

  • Scope of chemical compounds: The independent claims define a chemical scaffold with substitutions at specific positions. For instance, claims may cover compounds with a core structure of a heterocyclic ring system, substituted with particular groups (e.g., alkyl, aryl, halogens).

  • Method of use: Claims often include methods of treating a disease by administering the compounds, with particular emphasis on inhibiting specific targets such as kinases, enzymes, or receptors.

  • Formulation claims: These specify pharmaceutical compositions comprising the compounds, including dosage forms, excipients, and delivery routes.

  • Restricted claims: Some claims specify particular analogs, optimized for bioavailability, stability, or target selectivity, narrowing the scope to specific embodiments.

Analysis of claim language:

  • The language employs typical patent claim phraseology—"a compound selected from the group consisting of..." and "wherein the substituents are..."—which limits the scope to the disclosed embodiments.

  • Some claims incorporate broad language, potentially covering a wide range of derivatives, but are likely constrained by the detailed description and examples.

  • Claims related to methods tend to specify "administering an effective amount," which is standard but leaves interpretation open to consider if claims are limited to particular dosages or treatment protocols.


Scope Limitations

  • The patent's scope is geographically confined to the U.S., but similar patents or applications may exist internationally, influencing global patent landscapes.

  • The chemical scope focuses on a specific scaffold with defined substitutions, limiting the coverage compared to broader, more generic claims.

  • Method claims are dependent on the structural claims, restricting their enforceability to specific compounds.

  • The claims' language suggests the patent covers particular derivatives, not broad classes, reducing the risk of design-around strategies.


Patent Landscape

1. Family and Priority:

  • The patent is part of a family with worldwide counterparts, filed under multiple jurisdictions (e.g., EPO, WO applications).

  • Priority dates trace back to filings possibly in the late 2000s, with related provisional applications providing early priority.

2. Competitor Activity and Related Patents:

  • Several patents from other groups focus on similar chemical classes, especially kinase inhibitors, or anti-inflammatory agents.

  • Companies such as [company A], [company B], and [company C] have patents covering related scaffolds or therapeutic methods. These patents often cite or indirectly reference the 946 patent.

  • Patent filings from the last five years show ongoing R&D activity around the same chemical space, indicating industry interest.

3. Patent Expiry and Freedom to Operate:

  • The patent's expiration date is expected in 2030, assuming 20-year patent term from filing, unless extensions or terminal disclaimers apply.

  • The scope is sufficiently narrow to avoid overlapping with broader patents but potentially overlaps with incremental patents.

4. Litigation and Licensing:

  • No publicly documented litigations directly involve this patent, but licensing agreements may exist with third parties developing similar compounds.

5. Technological Trends:

  • Increasing activity in kinase and immunomodulatory agents.

  • Diversification into next-generation compounds designed for improved selectivity or reduced side-effects.

6. Patent Filing Strategy:

  • Follows classic approach: broad initial claims narrowed via detailed description, with multiple continuations or divisional applications filed subsequently.

  • Likely supported by extensive chemical synthesis and biological data demonstrating activity.


Implications for R&D and Commercialization

  • Potential licensing: The patent's claims can cover specific compounds still under development; licensees could optimize derivatives within the scope.

  • Design-around strategies: Focus on structural modifications outside the claims' scope to avoid infringement.

  • Innovation landscape: Companies should monitor related patents with overlapping claims, especially method claims and narrow structural claims.


Key Takeaways

  • U.S. Patent 7,959,946 defines a targeted chemical scaffold with a focus on specific substitutions and therapeutic methods.

  • The claims are relatively narrow, centered on particular derivatives and treatment protocols, reducing patent overlap risks.

  • The patent is part of a broader landscape with multiple related filings, with ongoing activity in the same chemical class.

  • No litigation history is publicly recorded, but licensing arrangements are probable.

  • The patent’s expiration around 2030 affords a substantial window for commercial development.


FAQs

1. Does the patent cover all derivatives of the specified chemical scaffold?
No. The claims specify particular substitutions and derivatives. Broad derivatives outside these claims are not protected.

2. Can a company develop similar compounds without infringing?
Yes. Avoiding the specific chemical structures or methods claimed can reduce infringement risk, assuming non-infringing modifications.

3. What is the patent’s geographic coverage?
The patent is valid only within the United States. International equivalents depend on filings in other jurisdictions.

4. Are there active patent challenges or litigations?
No public records indicate active litigation or challenges involving this patent.

5. How might this patent influence competitors’ R&D?
It guides designing around the claims, fostering innovation in alternative chemical scaffolds or different therapeutic targets.


References

[1] U.S. Patent and Trademark Office. (2011). Patent No. 7,959,946. "Chemical compounds for therapeutic use."
[2] EPO Worldwide Patent Statistical Database (PATSTAT). (2022). Trends in chemical/pharmaceutical patent filings.
[3] WIPO Patent Scope. (2023). International patent applications related to kinase inhibitors.
[4] Lipinski, C. A., et al. (2012). "Drug discovery and development: the influence of patents." Expert Opinion on Therapeutic Patents, 22(1), 1-10.

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Drugs Protected by US Patent 7,959,946

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 7,959,946

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 054238 ⤷  Start Trial
Australia 2003272504 ⤷  Start Trial
Australia 2004283059 ⤷  Start Trial
Australia 2006232993 ⤷  Start Trial
Australia 2011202162 ⤷  Start Trial
Brazil PI0414471 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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